Informed ConsentInformed Consent

Improving Resident Efficiency and Improving Resident Efficiency and CompetencyCompetency

Informed Consent BasicsInformed Consent Basics

• At the root of any informed consent is understanding of the procedure, its intended benefit, complications and their likelihood, and alternatives to the procedure

• The Handbook of Interventional Radiologic Procedures (Lippencott Williams & Wilkins) provides adequate explanation of any procedure you will be consenting for.

• The following slides are aimed at preparing you for everything else

Why is this important? Why is this important? 2003 study in Europe was the only study to examine patient and physician opinions on informed consent as of a Pubmed search of 11/2013

786 interventional radiologists (attending level) polled-Respondents were asked whether they felt patients received adequate explanation regarding indications for intervention, the procedure, alternative treatment options, and complications. (Junior medical staff obtained consent in 58% of cases)

-Only 69% of respondents were satisfied with their level of explanation regarding indications for treatment-Only 79% felt that they adequately explained the procedure.

-No formal studies on IR related informed consent are available in the United States literature.

-No studies have been published that documented junior medical staffs comfort level of the procedure and consent for the procedure

The Dichotomy The Dichotomy

How we see it How the patient sees it

Components of Informed ConsentComponents of Informed Consent

• Disclosure– Informer must supply the subject

with enough information to make an autonomous decision

• Capacity– Patient must both understand the

information provided and form a reasonable judgment based on the potential consequences of his/her decision.

• Voluntariness– Patient has a right to freely

exercise his/her decision making without being subjected to external pressure such as coercion, manipulation, or undue influence

Informed ConsentInformed Consent6 Components of a true informed consent:

1. The purpose and nature of the procedure or treatment.

2. The method by which the procedure or treatment will be performed.

3. The risks, complications, and expected benefits or effects of such procedure or treatment.

4. The risk of not accepting the procedure or treatment.

5. Any reasonable alternatives to the procedure or

treatment and their most likely risks and benefits.

6. The right to refuse the procedure or treatment.

In Case of Emergency…In Case of Emergency…Here are the rules:

1. When any delay in treatment would jeopardize the health of a patient, and the patient is unable to give informed consent, the physician can imply consent.

2. If the patient is unable to consent and has a legally authorized representative who is available to consent, the treating physician must obtain the informed consent of the representative.

3. When informed consent cannot be obtained from the patient or from his or her legally authorized representative, the physician treating the patient should determine the immediacy of the need for treatment.

– a. A physician may provide any treatment or perform any procedure immediately required to prevent serious disability or death or to alleviate great pain and suffering.

– b.During the course of an operation or a procedure, a physician may perform any procedure that becomes necessary because of a condition discovered or arising during the operation or the procedure that presents an immediate threat to the life or the health of the patient.

4. Even if emergent, if patient is competent, they can deny a life saving procedure.

““Pain, Bleeding, Infection…”Pain, Bleeding, Infection…” Procedures vary greatly in complexity and associated complications. Complications are unique to each procedure. This is what we do, just to name a few :

Angioplasty and Vascular Stenting Aortic stent graft placement Biliary Interventions Catheter Angiography Catheter Embolization Catheter-directed Thrombolysis Chemoembolization Chest tube placement Chest port placement Dialysis access Dialysis and Fistula/Graft Declotting and Interventions Inferior Vena Cava Filter Placement and Removal Needle Biopsy under CT and Ultrasound guidance Renal AngiogramTunneled Central Venous Catheter Transjugular Intraheptic Portosystemic Shunt Procedure Transjugular Liver Biopsy

Needle Biopsy of the Thyroid Paracentesis and Thoracentesis Percutaneous Abscess Drainage Percutaneous Gastrostomy Radiofrequency Ablation of Tumors Transjugular Intrahepatic Portosystemic Shunt (TIPS) Uterine Fibroid Embolization Varicocele Embolization Vascular Access Procedures Vertebroplasty & Kyphoplasty Vascular Malformation Sclerotherapy Carotid Angiogram Chest Port Inferior Vena Cava FilterLiver Transarterial ChemoembolizationPercutaneous Abdominal or Pelvic DrainPercutaneous Dialysis Fistula Graft Radiofrequency AblationUterine Fibroid EmbolizationVertebroplasty and Kyphoplasty Yttrium-90 Radiotherapy

Central Venous AccessCentral Venous Access

Indications for PlacementIndications for Placement• Monitoring of the central venous pressure (CVP) in acutely ill patients to quantify

fluid balance • Long-term Intravenous antibiotics • Long-term Parenteral nutrition especially in chronically ill patients • Long-term pain medications • Chemotherapy • Drugs that are prone to cause phlebitis in peripheral veins

– KCl; Vasopressors; Amiodarone • Plasmapheresis• Peripheral blood stem cell collections (Trifusion)• Dialysis (Hickman)• Frequent blood draws • Frequent or persistent requirement for intravenous access • Need for intravenous therapy when peripheral venous access is impossible (rare)

Central Lines: Potential Central Lines: Potential Complications (Jugular access)Complications (Jugular access)

• Pneumothorax – range from 0.1-1% (more in SCV placement)• Delayed PTX – 0.5% of all pneumothoraces (>6h after placement)• Malposition – usually not an issue with image guided placements• Cardiac arrythmia – up to 25% - Usually resolves with withdrawl of wire but can

cause malignant arrythmia. • Guidewire loss• Catheter related thrombosis• Air embolism• Venous Perforation• Inability to place catheter• Others include Chylothorax (LIJV), lympohocutaneous fistula, • Vascular injury (Carotid puncture) – 1-6%. Use of ultrasound aids inadvertent arterial

puncture. – Up to 40% of Carotid punctures are associated with hematoma formation. Other

complications include stroke, AVF, psuedoaneurysm formation• Death

Postrprocedure : thrombosis, venous stenosis, infection, catheter fracture, air embolism on extraction

Complications by SiteComplications by Site

Central Lines – Complication Central Lines – Complication factorsfactors

1. Inexperience, variably defined but with a consistent relationship between less experience and the rate of complications.

2. Number of needle passes, with the incidence of complications rising with two venopunctures

3. Body mass index, previous catheterizations, and severe dehydration or hypovolemia are factors that increase risk.

4. Coagulopathies do not appear to increase the risk of percutaneous insertion, if appropriate measures are taken to attempt correction of coagulopathy.

5. Large catheter size6. Unsuccessful insertion attempts is the strongest predictor of

complication.

• Overall, 5-19% reported incidence of complications in ICU patients – much less in IR.

ParacentesisParacentesis

IndicationsIndications

• Diagnostic– New onset ascites – Suspected spontaneous or secondary SBP Including :

• Fever• Leukocytosis• Vomiting• Abdominal tenderness• Paralytic ileus

– New hospitalization or ER visit– Hepatic Encephalopathy– Renal Failure (new onset)– Worsening liver function

• Therapeutic– Respiratory compromise– Abdominal pain or pressure

Paracentesis ComplicationsParacentesis Complications

• Post paracentesis hypotension (73% if 5-8L)• Bacterial peritonitis (<1%)• Hemoperitoneum (<1%)• Abdominal wall hematoma (<1%)• Site infection• Ascitic leakage• Hyponatremia• Death

Paracentesis in thrombcytopeniaParacentesis in thrombcytopenia

• JVIR article Apr 2013– 304 Paras completed by Attendings and juniors– Platelets <50k (mean 38k): INR avg 1.6– <1% major bleeding complication (Req Transfusion)

**Bleeding complication risk is extremely low, unless organ or arterial injury occurs. **

NEJM does not recommend platelet or FFP transfusion preprocedure.

Hepatology: Albumin reduced post paracentesis circulatory dysfunction (PCD) events by 66% in patients with 5-8L removed. Above graph shows it superior to various other alternative treatments

•Albumin reduced hyponatremia events by 42% when compared with no treatment

•Reduced Death rates by 36%

ThoracentesisThoracentesis

IndicationsIndications

Diagnostic:– All new effusions

Therapeutic:– Respiratory distress

Contraindications• Chest wall cellulitis• Severe Coagulopathy• Severe lung disease (Pneumothorax risk)• Mechanical Ventilation (Decreased resealing)

Thoracentesis ComplicationsThoracentesis Complications

Major Complications:– Pneumothorax (3-30%)– Hemopneumothorax– Hemorrhage (0.2%)– Hypotension (vasovagal response) (0.6%)– Reexpansion pulmonary edema ().5% when >1L removed– Death

Minor Complications:- Dry tap (no fluid return)- Subcutaneous hematoma or seroma

(0.2%)- Anxiety

- Pain- Shortness of breath (1%)- Cough (0.8%)

IVC Filter PlacementIVC Filter Placement

Decision tree – Assesment of Filter placement, choice Decision tree – Assesment of Filter placement, choice of filter, method of placementof filter, method of placement

Indications and ACR guidelines – Indications and ACR guidelines – Filter placementFilter placement

Inferior vena cava filter placement is most commonly indicated for deep venous thrombosis (DVT) or pulmonary embolism when anticoagulation therapy is contraindicated. Other indications detailed in chart on prior slide

-Per the ACR Appropriate Criteria guidelines, free floating ileofemoral DVT is the only “usually appropriate” indication besides contraindication to anticoagulation and documented PE.

- Almost all other indications are considered “may be appropriate” per ACR.

IVC Filter Placement ComplicationsIVC Filter Placement Complications

• Venous Access site (<1%) – – Bleeding– Hematoma– Infection– AVF– Thrombosis

• PE despite filter placement – – 5.6% lifetime risk; Fatal in 3.7%

• IVC thrombosis – 2.7% – incidence varies by filter, but this can cause critical phlegmasia and

preclude removal.

Filters decrease the risk of PE, but increase the risk of DVT. De novo DVT rates approach 14% after filter placement.

Filter MalpositionFilter Malposition

• Highly variable – Due to operator experience– Minor malposition

• crossed filter legs or filter tilt (which decreases the efficacy of the filter)

– Major malposition :• Malposition in the IVC (suprarenal)• Deployment into a nonintended vein (dilated lumbar)• Filter migration.

– This can happen in the acute phase of deployment or can happen as the result of delayed migration.

– Patients must be aware, that despite rare, this can require major surgical intervention to fix.

Retrieval complicationsRetrieval complications

• Not all filters can be retrieved safely/successfully• IVC perforation by filter legs is common,

– Incidence ranging from 40-95%.• Aortic, ureteral, lumbar arterial, frank IVC rupture, duodenal perforation can

occur as a result of perforation . Frank IVC tear on retrieval can occur if the legs transgress the IVC

• Fractured struts are common, fractured baskets are uncommon (fortunately). Fractures struts are rarely of clinical significance, and can be left in place in the absence of problems.

• Device infection is luckily an extremely rare complication. – In select case reports, cultures from the device itself have turned up

negative. Tissue or clot debris in the filter have been the culprits in select cases.

• Death

Surgical excision of a right atrial Surgical excision of a right atrial filterfilter

Postprocedure managementPostprocedure management

IVC filter removal under anticoagulation is appropriate

Always schedule patient for retrieval

If you fail, Try Harder.

Transjugular Liver BiopsyTransjugular Liver Biopsy

IndicationsIndications

Patients with diffuse liver disease requiring biopsy with 1 or more of the following conditions:– Deranged coagulation– Massive ascites– Liver abnormalities such as peliosis hepatitis– In combination with transjugular intrahepatic

portosystemic shunt (TIPS) or venography– Any other contraindication for percutaneous biopsy– Failed percutaneous biopsy– Morbid obesity– Soft indication for pressure measurement to

determine functional portal hypertension

ComplicationsComplications

• The complications are access site - related and cardiac or hepatic complications.

– Liver capsule puncture– Liver hematoma– Hematobilia– Cardiac arrythmia– Portal vein – Arterial/Bilious fistula– Psuedoaneurysm– Renal failure/Contrast reaction– All vascular access complications. – Death

• The reported total complication rate is 7.1%. ( 1.3-20.2% depending on the source)

• Mortality rates of 0.09% (adults) and 0.1% (children) have also been reported.

• Mortality is due to hemorrhage from the liver or ventricular arrhythmia. Other complications included neck pain, hematoma in the neck, carotid artery puncture, pneumothorax

• A technical success rate of 96.8% has been reported in a recent meta-analysis that included more than 7500 cases. (3.2% conversion rate)

• Inability to catheterize the RHV was the most common reason (43.3%) for failure.

How often is conversion to percutaneous biopsy required?

• Average fluoroscopy time : 4 min• The mean duration of the procedure is 40 min• Radiation dose ranges from 0.5 - 1 mSv.

How long will the procedure take?

How common are nondiagnostic biopsies?

• Fragmentation rates vary between 10-24%

• Diagnostic sample rates vary between 2-10%

Common Patient Questions

Percutaneous GastrostomyPercutaneous Gastrostomy

Willis Oglesby (WOG) tube

IndicationsIndications

• Dysphagia due to neurological disorder

• Head and neck malignancies requiring surgical therapy or radiation that may inhibit access to nutrition

• Chronic disease states where the patient cannot fill caloric requirements by oral intake alone

• Intestinal disorders requiring special formula for feeding

• Palliative for gastric outlet obstruction or small bowel tumor

Why we do it, not GIWhy we do it, not GI

• Percutaneous radiological gastrostomy (PRG) has a success rate comparable to that of the Surgical/endoscopic method, with lower morbidity and mortality rates.

– PRG has a success rate at 99.2%, PEG (95.7%), Surgical (100%)– Total and major complication rates Surgery (29% and 19.9%, respectively); PEG

(15.4% and 9.4%); and PRG (13.3% and 5.9%) • May be performed in patients for whom the endoscopic method would be

difficult or dangerous, such as those with head and neck malignancies (can avoid potential complications with endo as well as the low associated tumor seeding rate)

We’re not always perfect …

ContraindicationsContraindicationsAbsolute• Uncorrected coagulopathy remains an absolute contraindication due to the possibility

of uncontrollable internal hemorrhage. – Preprocedure screening should be performed, and coagulopathy corrected– Suggested acceptable parameters include an International Normalized Ratio (INR) of 1.3 or

less and a platelet count of at least 80 × 109/L.– If possible, this procedure should also be avoided in patients with portal hypertension and

varices due to the potential for massive hemorrhage.Relative• Many patients requiring gastrostomy placement are immunosuppressed, either due to

their underlying illness or to the use of medications such as steroids.– Immunosuppression is associated with higher rates of pericatheter leakage,and this should

be considered in preprocedure assesment/consent.

• Interposition of either colon or liver between the stomach and anterior abdominal wall• Previous major gastric surgery• Ascites (if controllable through drainage or diuretics PRG can be considered.)

To pexy or not to pexy…To pexy or not to pexy…Support:

- Reduces the risk of initial peritoneal catheterization- Pericatheter gastric leakage- Later intraperitoneal tube migration

Also: - Replacement of dislodged tubes is easier, leading to lower rates of repeat gastrostomy (formation of adhesions maintains alignment and allows the mucocutaneous tract to mature earlier)

Animal studies have shown that when gastropexy is used, adhesion between the stomach and abdominal wall occurs as early as 24 hours after the procedure.

(It may also make the primary placement of larger tubes, which are believed to have lower occlusion rates, easier, and by acting as a tamponade, may decrease the risk of early gastric hemorrhage)

Against: - Thorton et al (2002) showed no difference in mortality, (N=48)

- Incidence of discomfort or erosion of T-Tacs has been reported, and discomfort can approach 20%.

- Additional gastric punctures may be associated with a higher risk of hemorrhage.

-Potential for T-fasteners to cause skin ischemia and pressure necrosis

-Gastropexy adds complexity and time, and as a result, cost, to the procedure.

ComplicationsComplicationsMajor complications:

– Peritonitis– Septicemia– Significant stomal infection– Aspiration– Hemorrhage– Gastrointestinal perforation– Dislodgment of tube requiring repeat

procedure or surgery

Minor complications:

-low-grade pericatheter leakage

- superficial stomal infection

- tube dislodgment not requiring repeat procedure

- tube occlusion

- tube or balloon rupture

Common Gastrostomy Tube Management Common Gastrostomy Tube Management Questions: A referenceQuestions: A reference

How do I clean the tube site?- Soap and water are recommended. Avoid hydrogen peroxide or alcohol as they may irritate the skin or inhibit healing. -Antibiotic creams are generally not recommended as they increase skin maceration

I’m getting nauseated with feeds, what do I do?- Gently pull back on the tube to ensure that it is sealed against the stomach wall, and not causing an outlet obstruction- Check the measurement to ensure that the tube is not post pyloric- Consider slowing the rate, (confirm with nutritionist)- If patient has a GJ tube – this may indicate significant underlying problem and the tube should be evaluated by fluoroscopy.

My tube looks infected… What do I do?- Antibiotic creams can be considered, but not for >5days- Determine nature of infection (purulent vs Candida) – Treat accordingly- Warmed sterile saline and sterile gauze can be used as a compress TID if bacterial infection is suspected. - If symptoms persist, schedule an appointment to be seen by a doctor.

Common Gastrostomy Tube Management Common Gastrostomy Tube Management Questions: A reference (cont’d)Questions: A reference (cont’d)

My tube is leaking… What do I do? - Upsizing the tube will usually only upsize the tract, and is not generally recommended- Check for residuals – you may be filling up a stomach that isn't emptying.- Pull back gently on the tube to ensure it is snug to the stomach wall- Tube may be cracked internally – consider fluoroscopic evaluation- Check balloon to ensure that it is not deflated- Barrier cream can be used to prevent skin breakdown- PPIs can be considered to decrease acidity of leaked contents, Motility agents can be considered to promote outflow and decrease pressure

My tube is clogging/is clogged … what do I do- Warm the tube prior to administering meds by indwelling warm water - Do not crush enteric meds and put them in the tube- Fill the tube with 1-3ml of carbonated water, dwell for 5 minutes, gently massage tube, then attempt to flush and aspirate- Pancreatic enzymes can be used if the patient is in house.

My tube just fell out … what do I do?- If the tract is immature (<6weeks) – go to the ER to be evaluated- If the tract is matured, a Foley can be placed that is 1fr size smaller than the initial G tube. Formal nonemergent replacement should be scheduled

Percutaneous NephrostomyPercutaneous Nephrostomy

Contraindictations

• Absolute– None

• Relative– Uncorrectable bleeding

diathesis or coagulopathy– Terminally ill patient to which no

quality of life benefit is expected (tube management is difficult)

– Pregnancy (radiation risk)

Success ratesSuccess rates

• Success rates generally vary by clinical scenario and operator, however here are the broadly generalized success rates by scenerio and threshold to maintain certification:

Complication Rates and ThresholdComplication Rates and Threshold

Common tube management Common tube management questionsquestions

1. When do I empty/change the bag? - Empty the bag before it is completely full. - Changing the bag is recommended only if there is leak or malfunction. The bag can also be

changed for cosmetic reasons.

2. Can I bathe or swim?- Never submerge the tube. Sponge baths are recommended to keep the dressing dry.

3. Can I shower?- You can take a shower if you put a plastic covering, such as Saran Wrap, over the area.

4. When do I change the dressing? - The dressing (gause) should be changed every 3 days or when it gets soiled, wet, or loose.

– Tegaderm should only be changed once a week or when it becomes soiled, wet, or loose.

BiopsiesBiopsies

Indications and ComplicationsIndications and Complications

• Complications vary highly by location and organ• Contraindications: Always be sure that the biopsy will

change management in some way.

Indications Contraindications

Success and Complication RatesSuccess and Complication Rates

Globally, you can quote to patients a 70-90% success rate for any percutaneous biopsy (excluding those not safely accessable)

Hypervascular organs (kidney/spleen) have 05.-2% “significant” bleeding rate with our traditional 19ga Temnos

Always consent for tract seeding

Transthoracic biopsy complicationsTransthoracic biopsy complications

Always consent for hemoptysis, pneumothorax, thoracostomy tube placement with admission, and death. Significant lung injury requiring admission is approximately. 2%

Source: SIR Guidelines for Percutaneous Biopsy

Tract SeedingTract Seeding• Tract seeding rates are highly variable based on

primary tumor. • Data is mostly limited to case reports, and large

volume studies are lacking. Some data is available, however:

– RCC risk has been estimated at 0.01%, with only 5 reported cases between 1977-2013.

– TCC (kidney) has an estimated rate of 3-5% seeding, and if TCC is suspected; direct surgical excision is recommended.

– As of 2008, metadata for HCC biopsy tract seeding approaches 2.7%.

• Most of the data comes from extrapolated data from HCC literature.

• As evidenced by the ACR/SIR guidelines on percutaneous biopsies: rates estimated to be less than 3.4%

• Specifically, large gauge needles, increased number of needle passes into the mass, end-cutting needles, and lack of a biopsy sheath have been implicated in tumor seeding of biopsy tracts

Tract seeding after Perc Neph

• McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med 2003;348:1123–1133.

• Major bleeding complication rate of ultrasound-guided paracentesis in thrombocytopenic patients S. Reardon, T.D. Atwell, A. Lekah Journal of vascular and interventional radiology : JVIR 1 April 2013 (volume 24 issue 4 Page S56 DOI: 10.1016/j.jvir.2013.01.129)

• Bernardi, Mauro, Caraceni, Paolo, Navickis, Roberta J. Wilkes, Mahlon M. Albumin infusion in patients undergoing large-volume paracentesis: A meta-analysis of randomized trial HepatologyVL - 55, IS - 4

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• Wojcik R, Cipolle M D, Fearen I, et al. Long term follow-up of trauma patients with a vena caval filter. J Trauma. 2000;49:839–843.

• Grande W J, Trerotola S O, Reilly P M, et al. Experience with the Recovery filter as a retrievable inferior vena cava filter. J Vasc Interv Radiol. 2005;16:1189–1193.

• Lin, M; Soo, T, Horn, L Successful Retrieval of an infected Gunther Tulip IVC filter. JVIR 2000;11:1341–1343

• Kalambokis G, Manousou P, Vibhakorn S, Marelli L, Cholongitas E, Senzolo M, et al. Transjugular liver biopsy--indications, adequacy, quality of specimens, and complications: A systematic review. J Hepatol. 2007;47:284–94.

• Yavuz K, Geyik S, Barton RE, Petersen B, Lakin P, Keller FS, et al. Transjugular liver biopsy via the left internal jugular vein. J Vasc Interv Radiol. 2007;18:237–41.

• Mammen T, Keshava SN, Eapen CE, Raghuram L, Moses V, Gopi K, et al. Transjugular liver biopsy: A retrospective analysis of 601 cases. J Vasc Interv Radiol. 2008;19:351–8.

• Dinkel HP, Wittchen K, Hoppe H, Dufour JF, Zimmermann A, Triller J. [Transjugular liver core biopsy: indications, results, and complications]. Rofo. Aug 2003;175(8):1112-9.

• Kalambokis G, Manousou P, Vibhakorn S, et al. Transjugular liver biopsy--indications, adequacy, quality of specimens, and complications--a systematic review. J Hepatol. Aug 2007;47(2):284-94.

• B Dhvasari, Intrahepatic delivery of feeds caused by a displaced percutaneous radiological gastrostomy catheter BJR March 1, 2009 vol. 82 no. 975 e48-e50

• Thornton F J, Fotheringham T, Haslam P J, et al. Percutaneous radiological gastrostomy with and without T-fastener gastropexy: a randomised comparison study. Cardiovasc Intervent Radiol. 2002;25:467–471

• Iilva MA, Hegab B, Hyde C, Guo B, Buckels JA, Mirza DF. Needle track seeding following biopsy of liver lesions in the diagnosis of hepatocellular cancer: a systematic review and meta-analysis. Gut. 2008;57:1592–1596.

• ACR guidelines for percutaneous nephrostomy http://www.acr.org/~/media/ebd04ede1f9b4a759eb253f65e5964ab.pdf• ACR guidelines for percutaneous biopsy

•Lyon, S Percutaneous gastrostomy and gastrojejunostomySemin ntervent Radiol. 2004 September; 21(3): 181–189.